DNA/RNA purification system, filtration system, and synthesizer for NCATS (COVID-19)

This is a Sources Sought notice. This is NOT a solicitation for quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The purpose of this notice is to also obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.  It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.  Responses will not be considered as proposals or quotes.  No award will be made as a result of this notice.  The Government will NOT be responsible for any costs incurred by the respondents to this notice.  This notice is strictly for research and information purposes only.

Background:  The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers.

The Therapeutic Development Branch (TDB) ASO lab program’s mission is to encourage and speed the development of new antisense oligonucleotides (ASOs) treatments for viral and rare diseases with high-unmet medical needs. To this end, TDB needs a DNA/RNA purification system, that allows for large scale purification. TDB also needs a DNA/RNA synthesizer, that allows for a range of scale 100 μmol – 8 mmol to speed up workflow and optimize cell culture work. TDB also needs an ultrafiltration and microfiltration system that allows for minimum working volume of 25 ml.  All three systems will support the ASO lab work for ASO treatment assay development and toxicity studies generally required in humans.

Project requirements: This is anticipated to be a COVID-19 related contract action for the following brand-name or equal items:

AKTA Pure 150 M, manufacturer: Cytiva, product no. 29046694. Brand equals must have the following salient characteristics:
Application: Tailored and reliable chromatography system for fast purification of proteins, peptides, and nucleic acids from microgram to tens of gram levels of target product.

Application supported: Affinity chromatography, size exclusion chromatography (SEC, also known as gel filtration), ion exchange chromatography, hydrophobic interaction chromatography, and reversed phase chromatography (RPC). For RPC runs use only Frac F9-R.

Flow cell path length: 2 mm (optional 0.5 mm and 10 mm)

Flow rate: 0.01 to 150 mL/min (normal range), 0.01 to 300 mL/min (column packing flow)

Multiple sample injection: Upgradeable to 5 samples

Multiple wavelength detection:           Up to 3 wavelengths

Multistep purification: Yes

Operating pressure (sample pump) max.: 5 MPa (725 psi)

Operating pressure max.: 5 Mpa (725 psi)

Power consumption: 300 VA

Protection class: IP 21

Pump type: Piston pump, metering type

Relative humidity: 20% to 95% (noncondensing)

Safety certifications: CE, ETL, UKCA, EAC, KC, RCM

Tubing i.d. (flow path): 0.75 mm

UV wavelength: 190 to 700 nm

Viscosity: 0.35 to 5.0 cP (system pump), 0.7 to 10.0 cP (sample pump)

Voltage: 100 to 120/220 to 240 VAC

pH monitoring: 0 to 14 (optional)

pH stability, cleaning-in-place (CIP): 0 to 14

pH stability, operational: 2 to 12

AKTA OligoPilot 100, manufacturer: Cytiva, product no. 18113679. Brand equals must have the following salient characteristics:

Application: For research, process development, and production.

Monomer Inlets: 8 fitted as standard [Option up to 12]

No. of Column Reactors: up to 7

No. of Waste Outlets: 8

Operating pressure max.: 20 bar (2900 psi)

Power Consumption: 600 VA

Pump Type: Piston pump, metering type

Recirculation: Yes

Storage Conditions: 4°C to 40°CRH: 10 to 95% non-condensed Atmospheric pressure: 84 to 106 kPa (840 to 1060mbar)

UV wavelength:           254 - 700 nm; 1 nm steps; 3 simultaneous wavelengths

Voltage: 100-120/220-240 V

AKTA Crossflow RePurposed, manufacturer: Cytiva, product no. 29409303. Brand equals must have the following salient characteristics:

Application: Well-suited for process development, filter screening, and process optimization at small scale.

Recirculation Volume Min.: 25 ml (with 1.7 mm i.d. tubing kit)

Operating pressure max.: 5.2 bar (75.4 psi)

Connections: UNF 5/16"

Hold-Up Volume Recirculation Line: < 20 ml (with 1.7 mm i.d. tubing kit, empty reservoir)

Mixing Principle: Magnetic stirrer

Material Compliance: USP Class V

pH Range: 2 - 12

Wavelength (Zn Lamp):          214 nm

Flow cell path length: 2 mm

Main Voltage: 100 to 240 V~ ±10%, 50–60Hz (Auto range)

Protection class: IP 20

Permeate Flow Rate Min.: 0.1 ml/min

Permeate Flow Rate Max.: 200 ml/min

Transfer Flow Rate Min.         : 0.1 ml/min

Transfer Flow Rate Max.: 200 ml/min

Anticipated period of performance:Award is anticipated in July or August 2021 with delivery of the items made F.O.B. Destination within 60 days after receipt of order (ARO) to: NCATS, 9800 Medical Center Drive, Rockville, MD 20850.

Capability statement /information sought: Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.  The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.  Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.
 

The respondent must also provide their  DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

All responses to this notice must be submitted electronically to Contracting Officer Mark McNally, mark.mcnally@nih.gov. Responses must be received by 11:59 AM, July 20, 2021.

Disclaimer and Important Notes:  This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).